APR January/February 2022 - 41

« MANUFACTURING
scrupulously sterilized, the cleanrooms must be sanitized - and the
cleanroom personnel themselves must be decontaminated. The
significance of proper decontamination procedures for cleanroom
personnel cannot be understated; most industry observers agree that
personnel are often the greatest source of cleanroom contamination.
To limit the spread of contaminants, cleanroom personnel must,
obviously, wear sterile gowns and use appropriate techniques for
donning and removing those gowns. The cleanroom itself must be
designed with unidirectional air currents to avoid inadvertently reintroducing
contaminants into the room.
Of course, the best possible way to remove the risk of personnel
contaminating the cleanroom would be to remove personnel from the
cleanroom. That's why many manufacturers have chosen to automate
portions of the fill-finish process using robotics. Most large-scale
operations today are highly automated, which minimizes the risk. For
small batches, however, many operations are still done by hand, so
meticulous cleanroom sanitation practices are essential.
Manual Processes Versus Automation
As an extreme quality control measure, the sterile fill/finish process relies
more on manual processes compared to most drug manufacturing.
However, aseptic processing has come a long way in 50 years and
automation is heavily used in aspects of the process, such as closed
vial filling, blow/fill/seal, and so on. Many of the larger commercially
available sterile filling lines are automated, with the exception of
preparing the bulk drug product. Such lines, however, are most
commonly in large scale commercial manufacturing.
In smaller scale operations, a number of processes must still be done
by hand. These include the addition of ingredients to a blender for
uniform mixing, and transferring this blended mix to a sterile filler.
Once the vials are filled, the next manual step is to transfer the vials to
a capper to seal the vials.
As discussed earlier, human intervention can lead to contamination
unless workers undergo and adhere to special aseptic training and
procedures. This training emphasizes proper operation of equipment
to ensure sterile conditions in the manufacturing rooms and to guard
against " shedding. "
Sterile Fill Considerations for
Large Molecules
APR quality-branding half JanFeb22.qxp_Layout 1 1/19/22 3:14 PM Page 1
It's not just sterility in the fill-finish process that affects a pharmaceutical
product's safety and effectiveness. Large molecules are much more
Why work
with AdvantaPure®
for your tubing needs?
* We're independent & employee owned. No big
conglomerate tells us how to run our business
or how to serve customers.
* Our team has decades of experience making SingleUse
tubing, container closures & assemblies.
Learn more today at
www.advantapure.com
A Solar Powered, Zero Landfill,
Employee Owned Company
888-884-6986 * Distributors Worldwide
NewAge Industries AdvantaPure® and NewAge® reg. TMs NewAge® Industries, Inc.
SOUTHAMPTON, PA, USA
* We offer high purity silicone, including high
pressure, low temperature & reinforced styles, & TPE.
* AdvantaPure is ISO 9001:2015 certified.
* Products are BPOG extractables tested & part of our
Rx-360 Joint Audit Program for Single-Use Systems.
MANUFACTURED BY
www.americanpharmaceuticalreview.com |
| 41
»
http://www.advantapure.com http://www.americanpharmaceuticalreview.com

APR January/February 2022

Table of Contents for the Digital Edition of APR January/February 2022

APR January/February 2022 - Cover1
APR January/February 2022 - Cover2
APR January/February 2022 - 1
APR January/February 2022 - 2
APR January/February 2022 - 3
APR January/February 2022 - 4
APR January/February 2022 - 5
APR January/February 2022 - 6
APR January/February 2022 - 7
APR January/February 2022 - 8
APR January/February 2022 - 9
APR January/February 2022 - 10
APR January/February 2022 - 11
APR January/February 2022 - 12
APR January/February 2022 - 13
APR January/February 2022 - 14
APR January/February 2022 - 15
APR January/February 2022 - 16
APR January/February 2022 - 17
APR January/February 2022 - 18
APR January/February 2022 - 19
APR January/February 2022 - 20
APR January/February 2022 - 21
APR January/February 2022 - 22
APR January/February 2022 - 23
APR January/February 2022 - 24
APR January/February 2022 - 25
APR January/February 2022 - 26
APR January/February 2022 - 27
APR January/February 2022 - 28
APR January/February 2022 - 29
APR January/February 2022 - 30
APR January/February 2022 - 31
APR January/February 2022 - 32
APR January/February 2022 - 33
APR January/February 2022 - 34
APR January/February 2022 - 35
APR January/February 2022 - 36
APR January/February 2022 - 37
APR January/February 2022 - 38
APR January/February 2022 - 39
APR January/February 2022 - 40
APR January/February 2022 - 41
APR January/February 2022 - 42
APR January/February 2022 - 43
APR January/February 2022 - 44
APR January/February 2022 - 45
APR January/February 2022 - 46
APR January/February 2022 - 47
APR January/February 2022 - 48
APR January/February 2022 - 49
APR January/February 2022 - 50
APR January/February 2022 - 51
APR January/February 2022 - 52
APR January/February 2022 - 53
APR January/February 2022 - 54
APR January/February 2022 - 55
APR January/February 2022 - 56
APR January/February 2022 - 57
APR January/February 2022 - 58
APR January/February 2022 - 59
APR January/February 2022 - 60
APR January/February 2022 - 61
APR January/February 2022 - 62
APR January/February 2022 - 63
APR January/February 2022 - 64
APR January/February 2022 - 65
APR January/February 2022 - 66
APR January/February 2022 - 67
APR January/February 2022 - 68
APR January/February 2022 - 69
APR January/February 2022 - 70
APR January/February 2022 - 71
APR January/February 2022 - 72
APR January/February 2022 - 73
APR January/February 2022 - 74
APR January/February 2022 - 75
APR January/February 2022 - 76
APR January/February 2022 - 77
APR January/February 2022 - 78
APR January/February 2022 - 79
APR January/February 2022 - 80
APR January/February 2022 - 81
APR January/February 2022 - 82
APR January/February 2022 - 83
APR January/February 2022 - 84
APR January/February 2022 - Cover3
APR January/February 2022 - Cover4
https://www.nxtbookmedia.com